Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening

BACKGROUND: The success of induced labor depends on the degree of ripening of cervix. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, this study has been conducted to prove the efficacy and safety of extraamniotic Foley catheter balloon and to compare it with intracervical prostaglandin E2 (PGE2) gel. METHODS: The randomized prospective study was conducted in the Department of Obstetrics and Gynecology and Medical Microbiology of Nehru Hospital. Hundred women attending the labor ward for induction of labor were divided into two groups: Group A--Foley catheter, Group B--PGE2 gel. Cervical swabs before and after the insertion of ripening agents were taken for culture studies. Placental membranes were also sent for culture. Labor outcome, side-effects, and complications were compared in both the groups. The statistical methods used were Student's compared t-test, Chi-square test, and Wilcoxon-Mann-Whitney test. RESULTS: Foley catheter proved to be a very effective preinduction ripening agent for unfavorable cervix compared with PGE2 gel, as is evident by the mean Bishop score at 12 h (P<0.001). Preparation delivery interval was significantly shorter (P<0.05) in women who underwent cervical ripening with Foley catheter balloon than with the PGE2 gel. No clinical evidence of chorioamnionitis was present in both the groups. CONCLUSION: This study concludes that extraamniotic Foley catheter balloon is an effective, safe, simple, low-cost, reversible, non-pharmacological mechanical method of preinduction cervical ripening.     

Cervical ripening. A review and recommendations for clinical practice.

Cervical ripening occurs before the onset of labor. The cervix is metabolically active during ripening and passive during active labor. A ripe cervix indicates readiness for labor and predicts successful induction of labor. Practitioners evaluate cervical readiness for labor using the Bishop score. Membrane stripping, mechanical dilators and prostaglandins are ripening methods used frequently because they are simple, effective, efficient, safe and well tolerated. Stripping of membranes, a Foley catheter and misoprostol tablets are less expensive than other available methods. Because prostaglandins may cause excessive myometrial activity and even labor, hospitalization and fetal monitoring are recommended. Despite their effectiveness, these methods often do not decrease the cesarean section rates. This finding may be explained by the fact that each study reviewed only included a small number of patients and that in most cases, amniotomy was done and induction started, when feasible, before the women reached a Bishop score > or = 9. Larger studies may have different outcomes. The type of ripening methods used depends on the urgency of the situation; balloon catheters and prostglandins often act within 12 hours, while membrane stripping is less predictable.     

Hyaluronidase versus Foley catheter for cervical ripening in high-risk term and post term pregnancies.

OBJECTIVE: To evaluate the effectiveness and safety of Foley catheter and hyaluronidase for cervical ripening. METHOD: Randomized controlled trial where 140 pregnant women, with gestational age > or = 37 weeks, indication for labor induction and an unripe cervix, were enrolled, allocated in two groups according to the method of cervical ripening before labor induction. Statistical analysis used Student's t-test, Mann-Whitney, Chi-square test, survival analysis, risk ratios and number needed to treat. RESULTS: Time of induction, dose of oxytocin and mode of delivery had better results in the Foley catheter group. Comfort with the method was higher in the hyaluronidase group. CONCLUSIONS: Both methods were effective and safe for cervical ripening. The Foley catheter group experienced a shorter period of induction, required a lower dose of oxytocin and had higher vaginal delivery rates, while the women who used hyaluronidase declared greater comfort with the method.     

Preinduction cervical ripening with the Foley catheter and the risk of subsequent preterm birth

OBJECTIVE: The Foley catheter is a safe and effective form of preinduction cervical ripening and is quickly growing in popularity. Its major effect appears to be through mechanical dilation, which has raised the concern that the use of the Foley catheter for cervical ripening may damage the cervix and result in a higher rate of subsequent preterm birth. STUDY DESIGN: We conducted a review of all induction of labor at our institution from July 1998 to July 2001 that required preinduction cervical ripening and had a subsequent birth. The primary outcome variable was preterm birth at <35 weeks of gestation. Demographic and potential confounding variables were analyzed. A probability value of <.05 was considered significant. RESULTS: The cases of 126 women (63 women in the Foley group and 63 women in the prostaglandin group) were studied. Women in the prostaglandin group had a prostaglandin agent used. There was no difference in maternal age, gravidity, parity, Bishop score, total time of induction, gestational age, oxytocin use, maximum oxytocin level, tobacco or drug use, or type of delivery in the index pregnancy between the groups. In the subsequent pregnancies, there were no differences in maternal age, gravidity, parity, spontaneous abortions, terminations, cone or Loop Electrosurgical Excision Procedure (LEEP) procedures, history of cervical manipulation, tobacco or drug use, stillbirth, need for induction, mode of delivery, episiotomy, gestational age at delivery, Apgar scores, labor duration, use of oxytocin, or birth weight. There were no differences in preterm birth at 37, 35, or 32 weeks of gestation between the groups. CONCLUSION: The use of the Foley catheter for preinduction cervical ripening does not appear to increase the risk of preterm birth in a subsequent pregnancy.     

Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial

OBJECTIVE: To compare the efficacy of transcervical Foley catheter alone (Foley) to transcervical Foley catheter with extraamniotic saline infusion for labor induction and cervical ripening in women with an unfavorable cervix. METHODS: This was a multicenter, randomized, controlled trial of women presenting for labor induction with a singleton, cephalic fetus, intact membranes, and unfavorable cervix (Bishop score 6 or less). Eligible women were randomly assigned to receive either Foley catheter alone or Foley catheter with extraamniotic saline infusion. All women received concurrent oxytocin administration. The primary study outcome was the induction-to-delivery interval. Secondary outcomes included cesarean delivery, maternal infectious outcomes, and immediate neonatal outcomes. Analysis was by intent to treat. RESULTS: One hundred eighty-eight women met eligibility criteria and were randomly assigned (Foley plus extraamniotic saline infusion, n=97; Foley, n=91). Baseline demographic characteristics, including parity, gestational age, and Bishop score were similar between the study groups. The median induction-to-delivery interval in the extraamniotic saline infusion arm (12.6 hours, interquartile range 9.3-18.8 hours) was similar to that in the Foley arm (13.4 hours, interquartile range 9.6-17.5 hours) (P=. 70). The proportion of women delivered by 24 hours was comparable between groups (delivery 24 hours, extraamniotic saline infusion 89.7%, Foley 87.9%, P=.70), as was the rate of cesarean delivery (Foley 18.7%, extraamniotic saline infusion 27.8%, P=.14). No significant differences were noted between the study groups with respect to rate of chorioamnionitis, endometritis, or immediate birth outcomes. CONCLUSION: In women with an unfavorable cervix, the addition of extraamniotic saline infusion to a transcervical Foley catheter does not improve efficacy for labor induction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00442663 LEVEL OF EVIDENCE: I.     

Preparation for Induction of Labour of the Unfavourable Cervix with Foley Catheter Compared with Vaginal Prostaglandin

Ripening of the unfavourable cervix prior to induction of labour using traction on a Foley catheter (32 patients) was compared with 40 mg of prostaglandin F2 alpha in Tylose gel applied to the external cervical os and held in place for 12 hours with a vaginal diaphragm (25 patients). Each patient in the above groups had a modified Bishop score of 0-3 and was randomly allocated to one or other group. Comparison was made with a further 25 patients in whom the cervical score was 4-6. Timing of amniotomy and commencement of Syntocinon infusion were equivalent for all patients. Prostaglandins conferred no advantage over Foley catheter in terms of amniotomy-delivery interval, operative delivery rate, and condition of the baby one minute after birth. The disadvantages of prostaglandins for cervical ripening are a longer preparation-delivery interval, and cost ($77 versus $4.75 for the Foley catheter). Currently, prostaglandins are not officially approved for use in Australia for induction of labour. It is suggested, therefore, that the Foley catheter is preferable for ripening the unfavourable cervix as a prelude to amniotomy.     

A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women

The objective of this study was to compare the efficacy and safety of intracervical Foley catheter with concurrent use of oxytocin versus vaginal misoprostol for labor induction in nulliparous women. Nulliparous women with Bishop score <6 who presented for labor induction were randomized to either 25 microg vaginal misoprostol every 4 hours followed by oxytocin, if indicated, or intracervical Foley catheter with simultaneous use of oxytocin. Among the 162 patients enrolled, 79 (49%) received misoprostol and 83 (51%) received Foley/oxytocin. We were unable to demonstrate a statistically significant difference between the misoprostol group and Foley/oxytocin group in the incidence of cesarean delivery (35% versus 29%; p = 0.37). The induction-to-delivery time was significantly shorter in the Foley/oxytocin group (18 versus 24 hours; p < 0.01). No differences in intrapartum complications, neonatal outcomes, or maternal morbidity were found. When compared with vaginal misoprostol, intracervical Foley catheter combined with oxytocin has a similar efficacy and safety profile for labor induction in nulliparous women. Foley/oxytocin results in a shorter induction-to-vaginal delivery time compared with misoprostol.     

Cervical ripening with the Foley catheter.

OBJECTIVE: To evaluate maternal and neonatal outcomes in a large series of patients undergoing cervical ripening with a Foley catheter. METHODS: The database of the Labor and Delivery Unit of the University of a teaching hospital in Italy was used to identify consecutive patients with a Bishop score (BS) of 4 or less who underwent pre-induction cervical ripening with a Foley catheter. The main outcome measures were clinical chorioamnionitis, endometritis, and suspected and culture-proven neonatal sepsis. RESULTS: Of 602 women undergoing cervical ripening with a Foley catheter, 160 (26.6%) went into active labor without additional interventions. Oxytocin was administered immediately after removal of the Foley catheter in 188 (31.2%) of the women, and 254 (42.2%) required an application of prostaglandin E2 vaginal gel. The cesarean delivery rate was 25.6%. The median time to delivery was 1469 min (range, 94-3350 min). Of the women who gave birth vaginally, 225 (50.2%) were delivered within 24 h. Clinical chorioamnionitis and postpartum endometritis occurred in 3 (0.5%) and 6 (1.0%) of the women, respectively. Neonatal sepsis was suspected in 4 (0.7%) of the newborns but blood culture results were negative in all cases. CONCLUSION: Transcervical use of the Foley catheter is safe for pre-induction cervical ripening, and the associated risk of maternal or perinatal infections is negligible.     

A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening

OBJECTIVES: The purpose of this study was to compare the efficacy of cervical ripening with 2 Foley catheter balloon volumes. STUDY DESIGN: Pregnant women admitted for induction of labor with a term singleton gestation were randomly assigned for cervical ripening by a balloon inflated with 30 mL or 80 mL of sterile saline. RESULTS: Two hundred and three women were included in the analysis. Ripening of the cervix with the larger balloon volume was associated with a significantly higher rate of post-ripening dilatation of 3 cm or more (76.0% vs 52.4%, P < .001). In primiparous women, the larger balloon volume resulted in a significantly higher rate of deliveries by 24 hours (71.4% vs 49%, P < .05), and a significantly less requirement of augmentation with oxytocin (69.3% vs 90.4%, P < .05). CONCLUSION: Ripening of the unfavorable cervix in primiparous women with a Foley catheter balloon inflated with 80 mL provided effective more dilatation, faster labor, and decreased need for oxytocin than with a balloon inflated with 30 mL of sterile saline.     

Extra-amniotic Foley catheter and prostaglandin E(2) gel for cervical ripening at term gestation.

OBJECTIVE: This study evaluated the efficacy of intravaginal prostaglandin E(2) gel in comparison with that of a Foley catheter for cervical ripening and induction of labor. STUDY DESIGN: Consecutive patients with unfavorable cervix requiring preinduction cervical ripening and induction of labor at term gestation were asked to participate in the study. One hundred and two patients were assigned to treatment with intravaginal prostaglandin E(2) gel (group 1) and 122 patients underwent the placement of an intracervical Foley catheter (group 2). After a maximum of three applications of intravaginal prostaglandin E(2) gel (18h) or after 18h from Foley catheter insertion oxytocin was administered to patients not in active labor. Labor profiles and pregnancy and neonatal outcome were compared between groups. RESULTS: The groups were comparable in term of demographic characteristics, indications for induction of labor, Bishop score at admission. The induction to labor time and the induction to delivery time were similar between groups. The cesarean sections rate was higher in group 1 than in group 2 (26.5 versus 14.7%, P<0.05). This remained significant when the analysis was restricted to nulliparous patients (32.3 versus 14.2%). The incidence of urinary tract infections, chorioamnionitis, and febrile morbidity was similar between groups. CONCLUSION: For preinduction cervical ripening, the Foley catheter is a valid alternative to the application of intravaginal prostaglandin E(2) gel and it is associated with a lower cesarean rate in nulliparous women.     

A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction

OBJECTIVE: The purpose of this study was to determine the efficacy of combination intravaginal misoprostol and intracervical Foley catheter for prelabor cervical ripening. STUDY DESIGN: A prospective, randomized controlled trial was conducted. Women who were undergoing labor induction, with a singleton gestation >or=28 weeks and an unfavorable cervix (Bishop score 相似文献   

Labor progression and risk of cesarean delivery in electively induced nulliparas

OBJECTIVE: To describe the pattern of labor progression and risk of cesarean delivery in women whose labor was electively induced. METHODS: We analyzed data on all low-risk, nulliparous women with an elective induction or spontaneous onset of labor between 37 + 0 and 40 + 6 weeks from January 2002 to March 2004 at a single institution. The median duration of labor by each centimeter of cervical dilation and the risk of cesarean delivery were computed for 143 women with preinduction cervical ripening and oxytocin induction, 286 women with oxytocin induction, and 1,771 women with a spontaneous onset of labor. An intracervical Foley catheter was used to ripen the cervix. RESULTS: Electively induced labor with cervical ripening had substantially slower latent and early active phases. After controlling for potential confounders, women who had an elective induction with cervical ripening had 3.5 times the risk of cesarean delivery during the first stage of labor (95% confidence interval 2.7-4.5), compared with those admitted in spontaneous labor. Elective induction without cervical ripening, on the other hand, was associated with a faster labor progression from 4 to 10 cm (266 compared with 358 minutes, P < .01) and did not increase the risk of cesarean delivery, compared with those in spontaneous labor. CONCLUSION: The pattern of labor progression differs substantially for women with an electively induced labor compared with those with spontaneous onset of labor. Furthermore, elective induction in nulliparous women with an unfavorable cervix has a high rate of labor arrest and a substantially increased risk of cesarean delivery. LEVEL OF EVIDENCE: II-2.     

Foley尿管水囊促宫颈成熟用于足月妊娠引产的前瞻性随机对照研究

目的 比较Foley尿管水囊与普贝生栓促宫颈成熟用于足月妊娠引产的安全性和有效性. 方法 采用前瞻性随机对照研究方法,选择2009年6月至12月在本院待产的孕足月、单胎头位、有引产指征、阴道清洁度≤Ⅱ度、胎膜完整、官颈Bishop评分＜6分的初产妇,签署随机对照研究知情同意书后,随机分为2组,最终纳入分析的共126例,分别予Foley尿管水囊(64例)和普贝生栓(62例)促官颈成熟,Foley尿管水囊组与普贝生栓组孕妇的孕周、引产前宫颈评分、引产指征差异无统计学意义.采用t、x2检验或Fisher精确概率法比较2组孕妇的引产成功率、分娩方式、产程时间及母儿结局. 结果 Foley尿管水囊组与普贝生栓组宫颈评分改善、引产成功率、阴道分娩率、总产程、产后出血量差异均无统计学意义(P＞0.05).Foley尿管水囊组较普贝生栓组引产24 h内阴道分娩率低[28.1％(18/64)与56.5％(35/62),t=10.37,P＜0.05],宫缩过频过强发生率也较低[0.0％(0/64)与17.7％(11/62),P＜0.05],但缩宫素使用率高[87.5％(56/64)与21.0％(13/62),x2 =56.27,P＜0.05].2组新生儿Apgar评分、羊水胎粪污染发生率、新生儿体重差异均无统计学意义(P＞0.05).2组孕妇无一例发生产褥感染. 结论 严格掌握Foley尿管水囊促宫颈成熟的指征及执行无菌操作规程,可以取得与普贝生栓相似的促官颈成熟效果及引产母婴结局,未发生过频过强官缩,具有安全性高及成本低廉等优点.     

Controlled-release dinoprostone insert versus Foley catheter for labor induction: a meta-analysis

Objective: To compare the effectiveness and safety of controlled-release dinoprostone insert with Foley catheter balloon for cervical ripening and labor induction.

Methods: PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and China Knowledge Resource Integrated Database were searched. Only randomized controlled trials comparing controlled-release dinoprostone insert with Foley catheter balloon were included. Risk ratio (RR) or mean difference (MD) with 95% con?dence interval (CI) was calculated.

Results: Six studies were included with 731 women received dinoprostone insert and 722 Foley catheter. Time from induction to delivery was significantly shortened in dinoprostone insert group compared to Foley catheter group (MD 5.73 h, 95% CI 1.26–10.20). There were no significant differences in vaginal delivery within 24 h (RR 0.75, 95% CI 0.43–1.30) or cesarean section (RR 0.94, 95% CI 0.80–1.12) between two ripening methods. Dinoprostone insert was related with increased rate of excessive uterine contraction (RR 0.07, 95% CI 0.03–0.19), but less oxytocin use (RR 1.86, 95% CI 1.25–2.77) when compared with Foley catheter.

Conclusions: Induction of labor with controlled-release dinoprostone insert seems to be more effective than Foley catheter. However, the former method causes excessive uterine contraction more frequently.     

Does Cervical Ripening at Term Using a High Volume Foley Catheter Result in a Lower Caesarean Section Rate Than a Low Volume Foley Catheter? A Systematic Review and Meta-Analysis

Cervical ripening with a Foley catheter before induction of labour is a common obstetrical intervention. In this study we aimed to evaluate primarily the relationship between high or low volume Foley catheters used for cervical ripening and Caesarean section, and secondarily the relationship between Foley catheter volume, cervical ripeness, and time to delivery. We searched Medline and Embase from their inceptions with the assistance of an experienced librarian. All abstracts and complete articles were independently reviewed by two reviewers, according to predefined inclusion criteria. Six hundred forty-eight abstracts were identified, and 30 complete articles were read in full. Three articles with a total of 575 participating women met the inclusion criteria. The rate of Caesarean section with use of 80 mL Foley catheters was not significantly different from the rate using 30 mL Foley catheters (RR 0.82; 95% CI 0.48 to 1.41). A favourable cervix (which was defined heterogeneously) was more common with high volume catheters (RR 1.72; 95% CI 1.46 to 2.04), and failure to deliver in 24 hours was lower (RR 0.70; 95% CI 0.54 to 0.90). High volume Foley catheters improve the likelihood of a favourable cervix and chance of delivery in 24 hours more than low volume Foley catheters. As a more favourable cervix before induction of labour is associated with a lower rate of Caesarean section, a randomized controlled trial comparing high and low volume Foley catheters for cervical ripening using Caesarean section as the primary outcome is warranted.     

Cervical ripening and induction of labor with misoprostol,dinoprostone gel,and a Foley catheter: a randomized trial of 3 techniques

OBJECTIVE: The purpose of this study was to compare the efficacy of 3 different techniques of cervical ripening and induction. STUDY DESIGN: Patients who required cervical ripening and induction were randomized to one of 3 groups: (1) supracervical Foley catheter and intravaginal dinoprostone gel, (2) supracervical Foley catheter and 100 microg oral doses of misoprostol, or (3) serial 100-microg oral doses of misoprostol. Intravenous oxytocin was administered when a protraction disorder of labor was identified. RESULTS: There were 339 women randomized. There was no significant difference in the time from first intervention to delivery in the 3 groups (P =.546). In each group, a similar percentage of women required oxytocin (P =.103). The rates of cesarean delivery were equivalent among the groups (P =.722). Rates of tachysystole were high but statistically equivalent among the 3 groups. There were no significant differences in Apgar scores or umbilical artery pH. CONCLUSION: Oral 100 microg serial doses of misoprostol, with or without the use of a supracervical Foley catheter, were equivalent to the use of a supracervical Foley catheter and serial 4-mg doses of dinoprostone gel for cervical ripening and the induction of labor.     

Induction of labour: which method to use?

Induction of labour is a common obstetric instrument to employ when the potential risk to continue a pregnancy is higher than to terminate it. The methods of induction can be pharmacological or mechanical; the choice of the method mainly depends by the cervical ripening, as it is significantly able to influence, according to the type of induction, its final issue. The mechanical methods are: stripping and sweeping of the membranes, hand dilatation of cervix, intrauterine pressure catheters, Laminaria Japonicum, transcervical Foley catheter and amniotomy. To pharmacological methods include some agents such as the prostaglandins (PG), the most common approach to induce a labour, and used above all by vaginal way in patients with unripe cervix. They simulate the natural PG effects at the beginning of delivery and show a great efficiency. There are a lot of PG on the market, but except some of them, as Dinoprostone for PGE2 and Misoprostol for PGE1, no one of them shows the same safety in management of labour. Oxytocin, another inductive method, administered by diluted intravenous infusion, is utilized alone or mainly with other methods when the labour is started or with rupture of the membranes, because it begins or maintains the myometrial contraction.     

Intracervical Foley catheter balloon vs. prostaglandin in preinduction cervical ripening.

OBJECTIVES: The aim of this study is to compare the effectiveness of the intracervical Foley balloon catheter and 3 mg prostaglandin E(2) tablet(s) in preinduction cervical ripening. METHODS: Ninety women referred to the maternity clinic for induction of labor with a Bishop score of less than or equal to 5 were randomized to receive an intracervical Foley catheter or prostaglandin E(2) tablets. The primary measured outcome was ripening of the cervix as measured with the Bishop score. RESULTS: There were no differences in mean Bishop scores between the prostaglandin and the Foley catheter groups. Bishop scores (mean+/-S.D.) after ripening were 6.6+/-0.80 and 6.7+/-0.86 for the Foley catheter and prostaglandin groups, respectively (P=0.54). The Foley catheter group showed a statistically shorter time to ripening compared with the prostaglandin group (3.4+/-2.1 and 6.5+/-3.2 h, respectively (P=0.001). There was no statistically significant difference in induction time (4.8+/-1.8 h and 5.3+/-2.4 h, respectively (P=0.36). CONCLUSIONS: There are no differences in preinduction cervical ripening efficacy between prostaglandin E(2) and the Foley catheter, but the Foley catheter has the advantage of ripening an unfavorable cervix in a shorter time.     

Cervical ripening with transcervical foley catheter and the risk of uterine rupture

OBJECTIVE: To estimate whether the rate of uterine rupture in patients with a previous cesarean delivery is related to labor induction and/or cervical ripening using transcervical Foley catheter. METHODS: Charts of all patients who had a trial of labor after a previous cesarean delivery in our institution between 1988 and 2002 were reviewed. The rates of successful vaginal birth after cesarean delivery and uterine rupture in patients with spontaneous labor (control group) were compared with those of patients who underwent a labor induction by means of amniotomy with or without oxytocin and patients who underwent a labor induction/cervical ripening using a transcervical Foley catheter. Logistic regression analysis was performed to adjust for confounding variables. RESULTS: Of 2479 patients, 1807 had a spontaneous labor, 417 had labor induced by amniotomy with or without oxytocin, and 255 had labor induced by using transcervical Foley catheter. The rate of successful vaginal birth after cesarean delivery was significantly different among the groups (78.0% versus 77.9% versus 55.7%, P <.001), but not the rate of uterine rupture (1.1% versus 1.2% versus 1.6%, P =.81). After adjusting for confounding variables, the odds ratio (OR) for successful vaginal birth after cesarean delivery was 0.68 (95% confidence interval [CI] 0.41, 1.15), and the OR for uterine rupture was 0.47 (95% CI 0.06, 3.59) in patients who underwent an induction of labor using a transcervical Foley catheter when compared with patients with spontaneous labor. CONCLUSION: Labor induction using a transcervical Foley catheter was not associated with an increased risk of uterine rupture.